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Immunovant · 8 hours ago

Associate Director Drug Product

United States

Full-time

Remote

Lead/Staff, Director/Executive

$185K/yr - $195K/yr

5+ years exp

Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. The Associate Director of Drug Product Development will be responsible for supporting ongoing drug product formulation and manufacturing at CMO partners, focusing on late-stage commercialization activities of biologic drug-device products.

BiopharmaBiotechnologyPharmaceutical

Hiring Manager

Mohammad Ouranus

Responsibilities

Lead and provide oversight to drug product (DP) process design, including characterization, technology transfer, and robust commercial validation

Serve on cross functional DP work streams and manages DP activities and documents (reviewing/authoring reports, and protocols) through Process Performance Qualification (PPQ), including registration stability study execution, process characterization planning and execution, tech transfer strategy, PPQ readiness, regulatory filings, PAI (Pre‐Approval Inspection) readiness, approval, and launch support

Provide technical oversight and use experience gained on scientific/technical issues to guide the team to investigate and close out deviations in timely manner to enable release of manufactured DP batches

Ensure integration of primary filled container closure and component specifications and testing with the combination product design

Work closely with CMC regulatory team and be accountable for DP CMC sections of filing. Review regulatory strategy and filing readiness and support preparations for agency meetings. Author and review regulatory submissions

Effectively/efficiently manage CDMOs and deliver success on drug product supply and BLA filing readiness

Qualification

Drug product process developmentProcess characterizationTechnology transferRegulatory submissionsScale-up of biologicsAnalytical methodsEffective communicationTeam collaboration

Required

B.S. in Chemical Engineering, Biochemical Engineering, Bio-engineering, Biochemistry, Microbiology, or related field with ten (10) or more years of relevant experience

OR Advanced degree in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceutics, Biochemistry, Microbiology, or related field with 5 or more years of relevant experience

Experience with drug product process development, process characterization, technology transfer and scale-up of processes to manufacturing scales of biologics (mAbs or fusion proteins)

Experience with drug product unit operations of manufacturing including freeze/thaw, mixing, filtration, filling and inspection of prefilled syringes

Working knowledge of regulatory requirements for commercialization including application of Quality by Design principles

Working understanding of analytical methods to characterize biologics

Experience with late-stage commercialization of biologics drug-device programs through PPQ and launch

Effective oral and written communication skills

Ability to effectively author or review technical reports, CMC/CTD sections for IND/IMPD, BLA/MAA filings

Ability to effectively articulate understanding of protein and process science to drive decision making on investigations of deviations, impact assessments, design of studies, etc., in a multi-disciplinary team-matrix environment